PROGRAM

Nomenclature of medical devices in the “product portfolio” of pharmaceutical companies:

• medical devices supplied with a medicinal product
• medical devices for drug delivery
• products that are integral with the medicinal product
• products for IVD, RUO (research use only) and general laboratory equipment
• medical / cosmetic / hygienic purpose of products
• aids (accessories)

Requirements of the international standard ISO 13485: 2018 Medical devices – Quality management systems – Requirements for regulatory purposes.

Requirements of the national standard DSTU EN ISO 13485: 2018 Medical devices. Quality management system. Regulatory requirements

The procedure for conducting audits of the QMS of companies producing medical devices.

Nikolay Matlaev, Lead Auditor of the Conformity Assessment Department of the Ukrainian Scientific Institute of Certification